Comparison of Automated Ventilator Controlled Weaning to Daily Spontaneous Breathing Trial Weaning Protocol in ICU Patients Following Prolonged Mechanical Ventilation.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- weaning time to successful spontaneous breathing trial
研究概览
简要总结
This study will compare Drager Smart Care (SC), a commercially available automated ventilator controlled weaning mode to the current daily spontaneous breathing trial (SBT) weaning protocol. The study is designed to determine if automated ventilator controlled weaning can reduce total duration of intubation following mechanical ventilation in ICU patients requiring prolonged mechanical ventilation (>72 hours).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Intubated with endotracheal tube
- •Requiring mechanical ventilation for > 72 hours
- •Meets weaning criteria: Improvement or resolution of the underlying process that precipitated need for mechanical ventilation, PaO2 ≥ 60 mm Hg on PEEP and FiO2 Requirements of ≤ 8 cm H2O and FiO2 ≤ 0.50, Stable oxygenation: PEEP and FiO2 requirements not increased in the past 24 hrs, Ability to initiate an inspiratory effort and trigger the ventilator, Subject enrollment approved by the primary service attending physician
排除标准
- •Pregnancy
- •Patients with tracheostomy or planned tracheostomy prior to attempt to extubate
- •Patients with known airway patency issues that are anticipated to delay extubation.
- •Patients with neurological injury in whom care is likely to be withdrawn
- •Patients with cervical spinal cord injury.
- •Prospective subject or surrogate consenter does not fully understand the implications of the study because of a language barrier.
研究组 & 干预措施
1 SmartCare
automated ventilator controlled adjustment of pressure support
干预措施: daily weaning trails (Other)
2 spontaneous breathing Trial
daily SBT on minimum pressure support
干预措施: daily weaning trails (Other)
结局指标
主要结局
weaning time to successful spontaneous breathing trial
时间窗: 28 days or extubation
weaning time to successful extubation
时间窗: 28 days or extubation
ventilator weaning days
时间窗: 28 days or extubation
total duration of ventilatory support
时间窗: 28 days or extubation
次要结局
- reintubations within 48 hours(48 hrs)
- ICU and hospital length of stay(total time of ICU and hospital stay)
- clinical staff time requirements(during active weaning period)
- sedation and analgesic requirements(28 days or extubation)